Standards and the Regulatory Landscape
Q. What roles do international standards – such as those from ASTM International – play in enhancing global regulatory convergence? What are some of the barriers to such convergence?
Hany Demian, U.S. Food and Drug Administration: International standards can promote regulatory convergence and help reduce uncertainty in the regulatory process. They provide the regulator with information and data consistently, predictably, and credibly, which lead to science-based decisions. Standards facilitate the evaluation of products through science-based methodologies and can streamline both the pre- and post-market review process. The consensus process is open to all stakeholders, including regulators.
For medical products and devices, the International Medical Device Regulatory Forum helps provide a regulatory perspective to those involved in the regulatory process. However, there are some barriers in some committees that need to be addressed to help optimize regulatory convergence. These include infrequent assessment and communication of committee strategic goals and objectives, lack of coordination among multiple standards developing bodies working independently on the same subject, limited number of available experts representing various stakeholder groups, discontinuity and inconsistency of project leadership, premature acceptance of under-developed new projects, and inconsistent regulatory adoption of standards because of the differences in laws and regulation in different countries.
Patty Edwards, U.S. Consumer Product Safety Commission: Convergence, alignment, and harmonization of global standards for consumer products has been of interest to stakeholders for years. Consider toys. Since the enactment of the Consumer Product Safety Improvement Act of 2008, stakeholders have been interested in aligning safety requirements as a potential means of ensuring safer toys worldwide. CPSC’s safety regulation for toys (16 CFR part 1250) references ASTM’s toy safety standard, F963-17, with one modification. Accordingly, all toys sold in the United States must comply with this standard. In contrast, toys sold in Europe and in other regions may or may not comply with ASTM F963-17. Different requirements from multiple jurisdictions typically add complexity to manufacturing and distribution, increasing the risk of error. Therefore, stakeholders are working toward aligning toy safety standards. Aligning safety standards could help address these concerns and may reduce production and distribution errors. However, all stakeholders, including international regulators, should acknowledge that alignment alone does not ensure safer products. CPSC staff supports global convergence of standards or regulations when the result does not compromise safety.
Elise Owen, U.S. Environmental Protection Agency: International standards play a critical role in enhancing global regulatory convergence. The World Trade Organization Technical Barriers to Trade Agreement requires the use of relevant international standards in regulations, except where ineffective or inappropriate to achieve important objectives like the protection of human health, safety, and the environment. In the United States, these WTO obligations are reinforced in national law and policy. In addition, U.S. laws and policies also direct federal agencies to give preference to performance standards (rather than prescriptive standards), to consider using standards used by our trading partners, and to consider allowing the use of multiple standards for our regulatory, procurement, or other programmatic needs. I believe that these approaches further support global regulatory convergence.
Greg Saunders, U.S. Department of Defense: Somebody said that the great thing about standards is that there are so many to choose from. That person was, of course, being sarcastic. Standards paradise would be one standard, one test, accepted everywhere, but we are a long way from that ideal. That ASTM International has made it a top priority for at least the last 20 years to engage in truly global standards development helps move toward that ideal. Standards development that includes input from around the world — from highly developed nations as well as emerging nations — has a better chance of being both acceptable to and usable by those nations who sat at the table. Manufacturers would love to see fewer and more stable regulations to which they have to comply. Globally developed and accepted standards move us in that direction.
Unfortunately, competition in the standards world tends to work in the opposite direction. Where government entities — local, national, or regional — adopt unique standards into their regulations, it adds to the confusion and, for manufacturers, complicates meeting those regulations. The very old argument of what constitutes an “international standard” continues to make it difficult for governments to know where to look for standards that will enhance global interoperability and regulatory coherence.
Another looming hurdle is the argument over the availability of standards that are incorporated by reference into law or regulation. Some have asserted that such standards should be made available for free. That would represent a dramatic change to the business models of many SDOs that rely on the sale of documents to support their infrastructure.
While there has always been some tension between regulators and standards developers in some technical areas, in many cases industry and regulators have discovered a mutually beneficial synergy. When industry gets a chance to participate in development of technical requirements that may eventually become elements of a regulation it can generate a better result for both the regulators and the regulated community. That synergy could be threatened by a requirement for SDOs to make their standards available free on the internet.
What are some the emerging issues that could change public/private collaboration in standards development at your agency?
Demian: There are always emerging issues that need to be assessed periodically during standards development. These issues include, but are not limited to, standards that identify ways to help reduce the regulatory burden, and many technological areas of innovation such as “smart” devices, additive manufacturing, continuous manufacturing, regenerative medicine, nanotechnology, robotic surgery, imaging systems, customized implants, and artificial intelligence.
To help enhance the public/private collaboration, we need to consider more frequent goal assessment and communication by subcommittees and task groups, avoiding duplication of work, addressing limited resources by providing alternative ways to participate (e.g., WebEx meetings), addressing the project leadership inconsistency; soliciting new members to help develop standards for emerging technologies, and arranging more workshops on emerging technologies to help identify opportunities for standards development.
Edwards: The Internet of Things is a significant emerging issue for the CPSC. Our jurisdiction covers consumer product safety, rather than cybersecurity and privacy. And although IoT isn’t a consumer product, consumer products can connect to a network. Assessing IoT safety hazards addressable through voluntary standards is a significant undertaking. And identifying all of the potential stakeholders interested in collaborating is a much-needed early step and also a major challenge.
For instance, conducting a hazard assessment for an IoT product may identify a specific consumer safety risk. Once identified, collaborators need to determine what standard is best suited to address the risk. The answer to this question is not straightforward. Should the hazard be addressed universally through software or network standards? Or should the hazard be addressed specifically with the product’s particular safety standard? What provisions should be made for updates or planned obsolescence, as internet communication and other protocols evolve? How should interdependence between products be addressed to ensure collective system safety performance? Each of these potential avenues to address safety hazards may have a different set of collaborators, making the issue all the more complex. Additional emerging technologies that present challenges at CPSC are 3D printing, artificial intelligence, and wearable technologies.
Owen: Here in the United States, our laws and policies are highly supportive of public/private collaboration in the development of voluntary consensus standards. Federal agencies like EPA are required to participate in this development when it is in the public interest and compatible with agency and departmental missions, authorities, priorities, and budget resources. This can help EPA carry out our mission more efficiently while also reducing the burden on our regulated communities. Federal policy outlines key attributes or elements of a voluntary consensus standards process, including balance, and states that the “standards development process should be balanced. Specifically, there should be meaningful involvement from a broad range of parties, with no single interest dominating the decision-making.”
I am always impressed by the agility of the U.S. private sector-led standardization system in responding to emerging needs in standardization — this can support innovation in the marketplace, and can also support the work of federal agencies like EPA. At the same time, it creates a critical need to ensure that new stakeholders (who may have never been involved in standardization work in the past) are engaged and given tools to participate effectively. Ensuring meaningful involvement from a broad range of parties (and that the constitution of technical committees reflects the range of interests on a particular topic) helps keep the public/private collaboration in standards development strong.
Saunders: Stifling the long-standing, mutually beneficial public-private collaboration is the loss of technical expertise, the lack of travel funds, and not recognizing the long-term benefits from this partnership. These are not unique to government, but we have exacerbated the problem by contracting out so much technical development that in some areas we are virtually dependent on the private sector to provide needed expertise. Where we have the expertise we have, in some cases, become so inward facing that we simply don’t provide the opportunities — travel to standards meetings and conferences — where that expertise can be leveraged and shared. Perhaps most disappointing is the failure to recognize the long-term benefits of engagement. It is difficult to quantify how much benefit an agency gains from regular engagement in standards development. The benefits include leveraging the knowledge and experience of our scientists and engineers and establishing contacts. My own experience has been that I’ve gotten to know people who I can call for advice, consult with on new ideas, ask for help, and share knowledge. It’s impossible to quantify the benefit to DOD, but it’s definitely huge.
Enhancing collaboration is the growth of virtual participation. As we find better ways to involve participants who are not physically present and better manage meetings with virtual participants, we can connect with people who can’t afford the time or money to travel around the world to participate. I have participated in meetings in China, India, and various European cities (not to mention far-flung U.S. cities) from my desk at work. We have to get a lot better at this, but the growing expertise, technology, and willingness of meeting conveners to include virtual participants may help to mitigate at least some of the stifling effects mentioned earlier.
Hany Demian is the U.S. Food and Drug Administration’s standards executive, Office of the Chief Scientist in the Office of the Commissioner. Demian, who joined ASTM International in 1995, works on the committee on medical and surgical materials and devices (F04), where he is a member at large on the executive subcommittee. He is also active in committees on nanotechnology (E56), flexible barrier packaging (F02), and additive manufacturing (F42).
Elise Owen is the standards executive at the U.S. Environmental Protection Agency and a director at large on the board of the American National Standards Institute.
Patty Edwards is the voluntary standards coordinator at the U.S. Consumer Product Safety Commission. An ASTM International member since 1997, Edwards is active on the committee on consumer products (F15), where she is member at large on the executive subcommittee. She is also a member of several other consumer-related committees.
Gregory E. Saunders is director of the Defense Standardization Program Office at the U.S. Department of Defense. A former ASTM International chairman of the board who has been an ASTM member since 1984, Saunders is a member of the committee on aerospace and aircraft (F07).